The following data is part of a premarket notification filed by Sofamor Danek Mfg., Inc. with the FDA for Danek(tm) Spinal Epidural Endoscopic Sy.
| Device ID | K930191 |
| 510k Number | K930191 |
| Device Name: | DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY |
| Classification | Arthroscope |
| Applicant | SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis, TN 38131 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis, TN 38131 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-14 |
| Decision Date | 1995-09-26 |